Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
841–864 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS,...
K022525 · JJS
Bio-Rad
Immunology · 15d
Cleared Aug 14, 2002
RHIGENE MESACUP-2 TEST RNP, MODEL M7741
K022017 · LKO
Rhigene, Inc.
Immunology · 55d
Cleared Aug 14, 2002
K-ASSAY HS-CRP CONTROLS
K022486 · DCK
Kamiya Biomedical Co.
Immunology · 16d
Cleared Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
K020672 · JZO
Roche Diagnostics Corp.
Immunology · 157d
Cleared Jul 30, 2002
NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
K021231 · MMW
Matritech, Inc.
Immunology · 103d
Cleared Jul 30, 2002
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
K021482 · NIY
Inova Diagnostics, Inc.
Immunology · 83d
Cleared Jul 29, 2002
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
K013263 · LKP
Fred Hutchinson Cancer Research Center
Immunology · 301d
Cleared Jul 29, 2002
CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
K021757 · DCN
Good Biotech Corp.
Immunology · 61d
Cleared Jul 24, 2002
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
K020828 · LTK
Bayer Corp.
Immunology · 132d
Cleared Jul 23, 2002
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
K021516 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 74d
Cleared Jul 19, 2002
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT
K021572 · DCN
Beckman Coulter, Inc.
Immunology · 66d
Cleared Jul 16, 2002
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
K022041 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 22d
Cleared Jul 16, 2002
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
K022083 · CFN
The Binding Site, Ltd.
Immunology · 20d
Cleared Jul 12, 2002
QAB2A IGM ELISA KIT HRP
K021610 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 12, 2002
QAB2A IGG ELISA KIT HRP
K021611 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 57d
Cleared Jul 11, 2002
CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
K021882 · DCN
Good Biotech Corp.
Immunology · 34d
Cleared Jul 09, 2002
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
K021394 · DHR
Diamedix Corp.
Immunology · 68d
Cleared Jul 05, 2002
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
K022018 · LJM
Rhigene, Inc.
Immunology · 15d
Cleared Jun 27, 2002
RDI HS CRP CALIBRATOR SET
K021607 · JIT
Reference Diagnostics, Inc.
Immunology · 42d
Cleared Jun 21, 2002
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980 · JIT
Dade Behring, Inc.
Immunology · 87d
Cleared Jun 17, 2002
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070...
K021081 · DFZ
The Binding Site, Ltd.
Immunology · 75d
Cleared Jun 10, 2002
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
K021381 · JJY
Dade Behring, Inc.
Immunology · 40d
Cleared Jun 04, 2002
HYPERION VISIQUANT ANA TEST KIT
K013213 · DHN
Hyperion, Inc.
Immunology · 251d
Cleared Jun 03, 2002
ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)
K021257 · LKJ
Diagnostic Products Corp.
Immunology · 45d